Most respiratory diseases of the neonate occur as a result of the immaturity of the premature neonate's lungs. Despite stimulation, the normal process involved in the first breath does not occur. The respiratory system is underdeveloped and adequate gas exchange cannot take place. With this, there is a need for respiratory support.
The bubble CPAP with the combined effects of CPAP and pressure oscillations from the bubbles provides a lung protective, safe and effective method of respiratory support to spontaneously breathing neonates.
The Bubble CPAP effectively maintains Functional Residual Capacity (FRC). Most lung diseases that lead to respiratory failure are commonly associated with a reduced FRC. Maintaining FRC is very important to premature neonates who have a greater tendency of airway closure when FRC falls below closing volume.
The bubble CPAP helps reduce the infant's Work of Breathing (WOB). In a prospective randomized cross over trial performed by Lee, Dunn et. al. (see Lee K S, Dunn M S, et al, A Comparison of Underwater Bubble Continuous Positive Airway Pressure in Premature Neonates Read for Extubation. Biol. Neonate 73: 69-75.1998 comparing bubble CPAP with ventilator-derived CPAP, results showed that there was a decrease in the infant's minute volume and respiratory rate with bubble CPAP. They observed chest vibrations caused by the pressure oscillations from the bubbling. These pressure oscillations, according to the study, are reverberated back into the infant's airway and may have provided an alternate form of gas exchange through the principle of facilitated diffusion. This physiologic effect of bubble CPAP may help improve gas exchange and reduce the infant's work of breathing. Measurements done in vitro by Pillow and Travadi (see Pillow J J. Travadi J N. Bubble CPAP: is the noise important? An in vitro study. Pediatr. Res 2005; 57: 826-830) as well as in vivo measurements on a baby on bubble CPAP confirmed that the pressure oscillations from the bubbling are transmitted into the neonate's airway and lungs.
The bubble CPAP may reduce the need for intubation and mechanical ventilation. In the multi-center comparative study of Avery, et. al. (see Avery M E, Tooley W H, Keller J B, Hurd S S, Bryan M H, Cotton R B, Epstein M E, Fitzhardinge P M, Hansen C B, Hansen N. Is chronic lung disease in low birth weight infants preventable? A survey of eight centers. Pediatrics 1987; 79:26-30) it was noted that the use of bubble CPAP avoided the need for intubation reducing the possibility of airway injury, aspirations and secondary infection associated with the use of the ET tube. Results also showed significant reduction in the need for mechanical ventilation that may minimize the possible incidence of barotrauma.
A historical control study performed by A M De Klerk and R K De Klerk (see A M de Klerk, R K de Klerk. Nasal continuous positive airway pressure and outcomes of pre-term infants. J. Paediatr. Child Health 2001; 114: 697-702) in the use of bubble CPAP further confirmed earlier results with data showing marked reduction in intubation and ventilation rates. There was also a decline in the number of days on oxygen and there were trends indicating less number of days on any respiratory support and to an earlier postnatal day of life when respiratory support is no longer needed.
The bubble CPAP tends to reduce the incidence of Chronic Lung Disease (CLD). Early treatment with bubble CPAP for infants with respiratory distress showed a change in the severity and duration of the disease. Significant reduction in the incidence of chronic lung disease which was defined as O2 dependence at 28 days postnatal age or 36 weeks corrected gestation had been noted in some multi-center and comparative studies.
A case-cohort study of Linda Van Marter and colleagues (see Marter L J, Pagano M, et al, Do Clinical Marker of Barotrauma and Oxygen Toxicity Explain Interhospital Variation in Rates of Chronic Lung Disease? Pediatrics, Vol 105 No 6: 1194-1202. June 2000) suggested that barotrauma and oxygen toxicity were linked with CLD and that most of the increased risk of CLD was a result of the initiation of mechanical ventilation. Comparison of different respiratory care in 3 hospitals supported earlier results of reduced incidence of CLD with the use of bubble CPAP. Similar outcomes are being reproduced in hospitals that have used bubble CPAP.
Faster recovery with less lung injury and better respiratory outcomes are possible using a cost-effective respiratory support system such as bubble CPAP.
The Basics of Bubble CPAP systems are really very simple. CPAP systems become confusing when you look at them as multiple hoses, gauges, tubes. To complicate matters more the circuit is connected at one end to a ventilator or blender and at the other end to a baby via a mask or nasal prongs.
Babies in the high humidity environment of an isolate pose unique problems and challenges. Additionally, CPAP therapy does not occur in a vacuum. The bedside nurse and respiratory therapist must understand the system well so that they can deal with the ongoing patient care problems and not spend all their time trying to make the CPAP “work”.
In the CPAP circuit, gas flows from the ventilator, blender or flow driver to the humidifier then to the patient. A drainage bag and pressure gauge are present to catch humidifier “rain out” and measure CPAP pressure. All CPAP humidifiers for neonates must be heated between 36.5 and 37.2 degrees Celsius.
The CPAP Interface connects the patient to the CPAP circuit and pressure. Without a good interface the benefits of the CPAP will not be effectively delivered. Nurses and Respiratory Therapists need to be comfortable, fitting and working with the CPAP interface. The three interface types are mask, tube and nasal prongs. Nasal prongs are the best type to use in neonates as the fit is better and the CPAP delivery can easily be assured. Hudson type nasal prongs are well regarded b many CPA P educators as the best type.
The CPAP pressure generator is a simple device that acts to increase the pressure inside the CPAP circuit. The pressure generator must be able to safely keep the pressure at the desired level and safeguard against high system pressures. The pressure generator for Bubble CPAP is a water bottle in which the expiratory limb of the circuit is immersed to a depth in centimeters that equals the desired CPAP pressure. Bubble CPAP may provide what some experts call “high frequency oscillation” effect. In theory this effect could be responsible for improving gas distribution in the lung.
Numerous innovations for the Continuous Positive Airway Pressure Device have been provided in the prior art that are described as follows. Even though these innovations may be suitable for the specific individual purposes to which they address, they differ from the present design as hereinafter contrasted. The following is a summary of those prior art patents most relevant to this application at hand, as well as a description outlining the difference between the features of the Continuous Positive Airway Pressure Device (CPAP) and the prior art.
U.S. Pat. No. 8,235,042 of Lionel Newman Jr. describes an apparatus for providing pressure into which a patient must exhale is provided. The canister has a canister axis and is disposed to hold liquid. The canister also has indicia of pressure on the canister. The apparatus also includes a substantially rigid lid disposed to substantially cover a mouth of the canister and having a first inlet through the lid. The apparatus also includes an adapter in the first inlet. The apparatus also includes a conduit being retained by the adapter such that the conduit is substantially immovable relative to the canister axis.
This patent describes an apparatus for providing pressure into which a patient must exhale but does not have the over loaded water feature that will remove water into the drainable cavity on the inside surface of the outer vessel to provide better adjustment setting of CPAP pressure. It also does not have a selection of different sized end caps for the hollow control tube to control the size of the bubble that is released by the hollow tube to increase or decrease the pressure swings in the respiratory circuit.
U.S. Pat. No. 8,225,787 of Lionel Newman Jr. describes an adjustable airway pressure system is provided. The system may include a cap and a canister. The cap may include a substantially hollow conduit having indicia indicative of a plurality of airway pressure values and adapted to receive and output exhaled gas. The conduit may have screw threads on an exterior surface of the conduit. The cap may also include an adjust collar circumscribing the conduit and having an interior surface with a second plurality of screw threads. The second plurality of screw threads may couple and be complementary to the first plurality of screw threads such that a rotation of the adjust collar causes the conduit to move in a substantially vertical direction. The conduit may be adapted to be adjusted to heights along a continuum. The canister may contain liquid and receive the conduit such that the received exhaled gas is output from the conduit into the liquid.
This patent describes an adjustable airway pressure system but also does not have the over loaded water feature that will remove water into the drainable cavity on the inside surface of the outer vessel to provide better adjustment setting of CPAP pressure. It also does not have a selection of different sized end caps for the hollow control tube to control the size of the bubble that is released by the hollow tube to increase or decrease the pressure swings in the respiratory circuit. It does not have the fine adjustment, having at least 4 adjustment points within 1 cm H20.
Patent No. 2010/0282256 A1 of Thomas C. Loescher et al. describes an apparatus configured to provide positive airway pressure in a respiratory circuit comprises a container configured to be filled to a preselected level with liquids; a drop tube assembly comprising a hollow gas tube rotatably mounted in said container having an upper end extending a static distance outwardly of the container and connected to a respiratory circuit downstream of a user, and a hollow drop tube reciprocally movable upwardly and downwardly in the liquid in response to rotational movement of the gas tube. The container is provided with a gas vent and a liquid fill port.
This patent describes an apparatus configured to provide positive airway pressure in a respiratory circuit system but also does not have the over loaded water feature that will remove water into the drainable cavity on the inside surface of the outer vessel to provide better adjustment setting of CPAP pressure or the inner pressure control vessel. It also does not have a selection of different sized end caps for the hollow control tube to control the size of the bubble that is released by the hollow tube to increase or decrease the pressure swings in the respiratory circuit. It does not have the fine adjustment means, having at least 4 adjustment points within 1 cm H20 using the dimple engagement mechanism engaging in the side of the rotating cap lower cylinder.
U.S. Pat. No. 7,077,154 of Harris C. Jacobs et al. describes an apparatus for effecting bubble CPAP. The apparatus includes a hollow vessel holding a liquid, a cap, and a positionable tube assembly. The positionable tube assembly comprises a guide tube and a positionable tube. The positionable tube is arranged to have a gas introduced through it and is located within the guide tube. The positionable tube is arranged to be slid to various discrete longitudinal positions with respect to the guide tube and to be held in any one of those discrete positions against accidental displacement so that the lower free end of the positionable tube is held at a desired position below the surface of the liquid.
This patent describes an apparatus for effecting bubble CPAP but has a large positionable tube assembly that does not give the precise control required or the different sized end caps for the hollow control tube to control the size of the bubbles. It does not have the fine adjustment means, having at least 4 adjustment points within 1 cm H20 using the dimple engagement mechanism engaging in the side of the rotating cap lower cylinder. It does not have the unique capabilities of the inner pressure control vessel.
U.S. Pat. No. 6,988,497 of Walter Levine describes a humidifier apparatus for operating at an air pressure is disclosed for use with a respiratory therapy breathing apparatus that provides a breathable gas supply to patients requiring higher concentrations of liquid vapor and gas pressure. The humidifier apparatus includes a feed liquid supply bag in fluid communication with a humidifier cartridge via a conduit. The conduit enables air to flow there through to equalize air pressure between the humidifier cartridge and the feed liquid supply bag in response to liquid being supplied to the humidifier cartridge.
This patent describes a humidifier apparatus for operating at an air pressure but does not offer the unique capabilities of the Continuous Positive Airway Pressure Device.
U.S. Pat. No. 6,805,120 of Craig Robert Jeffrey et al. describes a pressure regulator for regulating the expiratory flow in a CPAP system includes submerging a tube into a column of water. Improvements are included for adjusting the level to which the tube is submerged and for ensuring constant water level.
This patent describes a pressure regulator for regulating the expiratory flow in a CPAP system but still does not offer the unique capabilities of the Continuous Positive Airway Pressure Device.
None of these previous efforts, however, provides the benefits attendant with the Continuous Positive Airway Pressure Device. The present design achieves its intended purposes, objects and advantages over the prior art devices through a new, useful and unobvious combination of method steps and component elements, with the use of a minimum number of functioning parts, at a reasonable cost to manufacture, and by employing readily available materials.
In this respect, before explaining at least one embodiment of the Continuous Positive Airway Pressure Device in detail it is to be understood that the design is not limited in its application to the details of construction and to the arrangement of the components set forth in the following description or illustrated in the drawings. The Continuous Positive Airway Pressure Device is capable of other embodiments and of being practiced and carried out in various ways. In addition, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for designing of other structures, methods and systems for carrying out the several purposes of the present design. It is important, therefore, that the claims be regarded as including such equivalent construction insofar as they do not depart from the spirit and scope of the present application.